Since 2005 Sweden has a unique environmental classification system for pharmaceutical products. It is a self-declaration system where each pharmaceutical company is responsible for their own environmental information, which is published on the open web-based portal www.Fass.se". Prior to publication the environmental risk assessments are reviewed by IVL Swedish Environmental Research Institute (IVL) as an independent, external part. The present report describes the experiences from the review process during the year 2018. In 2018, 373 environmental risk assessments (ERAs) were sent in for review. Almost 60% of the reviewed assessments received the comment no remarks and were recommended to be published, whereas the other 40% were recommended or needed to be corrected before publication. The number of unique substances that were published at Fass.se during 2018 was 361. Of these substances a little more than half of them were exempted from classification, one fourth were classified regarding environmental risk, and the rest quarter could not gain any classification due to lack of data. The work of improving the review system is an on-going process. As a part of this work IVL performs studies and activities to increase the knowledge of pharmaceuticals in the environment. In 2018/2019 a model was developed for environmental assessment of pharmaceutical products, in regard to environmental risks related to emissions of Active Pharmaceutical Ingredient (API) from production processes and product carbon footprint in a life cycle perspective.
Elektricitet används som en viktig insatsvara över hela världen och dess efterfrågan ökar. Miljöpåverkan för produktion av elektricitet är väl utforskad, medan miljöpåverkan för distributionen i elnät inte är lika utforskat och formaliserat. Miljöpåverkan för distributionen påverkas av flera aspekter såsom hur elnätet är uppbyggt, vilka delar som ingår och hur stora överföringsförlusterna är. I denna studie används livscykelanalys (LCA) för att kvantitativt bedöma miljöpåverkan av Göteborg Energi Näts stadsnät för överföring av elektricitet, baserat på ett system- och helhetsperspektiv. Detta görs för tre olika spänningsnivåer, högspänning (130 kV), mellanspänning (10 kV) och lågspänning (0.4 kV). Studien har utförts i samarbete med Göteborg Energi Nät, med en referensgrupp bestående av representanter från Chalmers, ABB, Energiföretagen, Ellevio, Svenska Kraftnät och Göteborg Energi. Ett viktigt syfte med studien är att skapa en generell LCA-modell för beräkning av miljöpåverkan för eldistribution, samt ett ramverk för hur livscykelanalys på elnät kan genomföras. Underlaget ska kunna tillämpas i Göteborg Energi Näts verksamhet och av andra elnätsaktörer, till exempel vid investeringsbeslut.
To be able to assess the environmental consequences of pharmaceutical products, reliable, comparable and relevant information is needed about the environmental impacts along the life cycle of the product. This project has developed and proposed a model for environmental assessment of pharmaceutical products, in regard to environmental risks related to emissions of Active Pharmaceutical Ingredient (API) from production processes and product carbon footprint in a life cycle perspective. The two parts is intended to supplement and expand the current environmental classification at Fass.se, which covers environmental risks from release of API from patient excretion in Swedish water recipients. The model is aimed to facilitate comparability of performed assessments of products with the same API and allow for third party review and validation, to ensure credibility and quality of reported results. The environmental risk part of the proposed model includes production stages where API can be/is released to the environment and builds on the current environmental classification at Fass.se. The carbon footprint part of the model covers greenhouse gas emissions in a life cycle perspective. We propose to use the framework described in ISO 14025 for environmental product declarations and initiate the development of Product Category Rules (PCR) for pharmaceutical products. Different potential options for such development are outlined in the report. The proposed model is aimed to deliver product specific environmental assessment results that may be used in a wide variety of different applications to control, manage and reduce impacts along the pharmaceutical value chain and drive improvements in different parts of the chain. The report includes an overview of potential use of the information, such as pharmaceutical benefits subsidy systems, procurement, process and product improvement, guidance in product choice as well as assessments in conjunction with product approval. The actual intended application of results, however, needs to be better understood in order to prioritise and guide further development and implementation of the model.
In order to reduce the environmental impacts of pharmaceuticals, reliable, comparable and relevant information is needed about the impacts along the value chain. The objective of this project is to define and evaluate needs, requirements and use of product-specific environmental information by different actors. The evaluation has focused on five main application areas for the information: Assessments in conjunction with product approval, Product and process improvements, Benefit subsidy system, Procurement of pharmaceuticals, and Guidance in product choice and use. Based on these application areas, the study has mapped roles and responsibilities of different actors in the work to reduce environmental impacts along the pharmaceutical value chain: Authorities, Regions, Pharmacies and Pharmaceutical companies and supply chains. A review of the policy framework has also been performed. Challenges, drivers and opportunities have been identified – both on a general level and on application level. Based on the results, key elements for further development and proposed way forward have been defined. This includes shared goals, requirements and standards between the actors, integrating further development of the model with development of its applications, as well as creating market incentives. A “timeline” for further development and implementation is proposed, as well as recommendations for next steps.